Batch review performed on 14 december 2023.Lot 1907840: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 2025-02-16.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional device involved batch review performed on 14 december 2023.Gmk-sphere 02.12.0005r femoral component sphere cemented size 5 r () lot 1910668: (b)(4) items manufactured and released on 16-mar-2020.Expiration date: 2025-06-06.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by medacta r&d knee project manager: revision surgery of a gmk sphere implant after 3 year and 2 moths from primary due to tibia and femoral loosening.From visual inspection of the removed components sent bask for investigation, no residual cement can be noted on the distal surface of tibial baseplate and on the internal surfaces of the femoral component.Some halos is also noticeable, most likely due to the washing process.The articular surfaces of the tibial insert present some dents and small craters, like if a third body (like cement) was interposed.Articular surfaces of the femoral component is not damaged.Poor interdigitation between cement and implant can be related to multiple factors, most likely not implant related (such as cementation process, temperature, time, presence of fluids on the surfaces of cement interface).Absence of cement, is not an evidence of a faulty device.From preliminary investigation, there is no evidence that the event is related to a faulty device.Clinical evaluation performed by medacta medical affairs director: 3 years after primary cemented tka, both components get loose and need replacement.According to radiographs and pictures, a cementation problem can be suspected: the metal parts appear to be detached from cement, and no residual cement was visible on either explanted component.This type of phenomenon may happen when, for instance, cement application is delayed, but of course we cannot state that this is the ascertained cause of this case.However, we see no reason to suspect a faulty implant.
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